buprenorphine and naloxone (oral/sublingual)

What is the most important information I should know about buprenorphine and naloxone?

What is buprenorphine and naloxone?

Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Buprenorphine and naloxone is a combination medicine used to treat narcotic (opiate) addiction. Buprenorphine and naloxone is not for use as a pain medication.

Buprenorphine and naloxone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking buprenorphine and naloxone?

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, or seizures; or
• alcoholism, drug addiction, mental illness.

Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

How should I take buprenorphine and naloxone?

Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use buprenorphine and naloxone in larger amounts, or for longer than prescribed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use dry hands when handling this medicine. Place the sublingual tablet or film under your tongue. Place the buccal film against the inside of your cheek. Allow the medicine to dissolve slowly. Do not chew or swallow it whole.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using buprenorphine and naloxone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

Never crush or break a buprenorphine and naloxone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Keep track of your medicine. This medicine is a drug of abuse and you should be aware if anyone is using it improperly.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Overdose symptoms may include extreme drowsiness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, very slow breathing, or coma.

What should I avoid while taking buprenorphine and naloxone?

What are the possible side effects of buprenorphine and naloxone?

Like other narcotic medicines, buprenorphine and naloxone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

• weak or shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, loss of coordination, extreme weakness;
• blurred vision, slurred speech;
• liver problems --upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• opioid withdrawal symptoms --shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
• withdrawal symptoms;
• tongue pain, redness or numbness inside your mouth;
• nausea, vomiting, constipation;
• headache, back pain;
• fast or pounding heartbeats, increased sweating; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect buprenorphine and naloxone?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

• other narcotic medications --opioid pain medicine or prescription cough medicine;
• a sedative like Valium --diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others; or
• drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine.

This list is not complete. Other drugs may affect buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about buprenorphine and naloxone.